title: Health-related quality of life with adjuvant docetaxel- and trastuzumab-based regimens in patients with node-positive and high-risk node-negative, HER2-positive early breast cancer: results from the BCIRG 006 Study.
abstract: BACKGROUND
  This study aims to describe and compare health-related quality of life (HRQL) in patients with node-positive and high-risk node-negative HER2-positive early breast cancer receiving adjuvant docetaxel and trastuzumab-based or docetaxel-based regimens alone.
  
  
  METHODS
  Eligible patients (n = 3,222) were randomly assigned to either four cycles of adjuvant doxorubicin and cyclophosphamide followed by four cycles of docetaxel (AC→T) or one of two trastuzumab-containing regimens: adjuvant doxorubicin and cyclophosphamide followed by docetaxel plus trastuzumab administered for 1 year (AC→TH) or six cycles of docetaxel plus carboplatin combined with trastuzumab administered for 1 year (TCH). The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30 and BR-23 were administered at baseline, the start of cycle 4 (mid), and the end of chemotherapy (EOC), as well as at 6, 12, and 24 months after chemotherapy.
  
  
  RESULTS
  Compliance rates for the EORTC questionnaires were acceptable at 72%-93% of eligible patients out to the 12-month assessment. Systemic side effect (SE) change scores were significantly improved for TCH-treated patients compared with AC→TH and AC→T at EOC, suggesting improved tolerability. Physical functioning (PF) was only slightly worse at midpoint for those receiving TCH, compared with patients who were just starting on taxane in an AC→TH regimen, but was otherwise similar between arms. All treatment arms recovered from the deterioration in SE, PF, and Global Health Scale scores by 1 year and median future perspective change scores continued to improve throughout treatment and follow-up.
  
  
  CONCLUSIONS
  HRQL outcomes for adjuvant docetaxel and trastuzumab-based regimens are favorable and support TCH as a more tolerable treatment option.
authors.affiliation: Cross Cancer Institute, University of Alberta, Edmonton, Alberta, Canada.
authors.forename: Heather-Jane
authors.initials: HJ
authors.lastname: Au
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Eiermann
authors.forename: Nicholas J
authors.initials: NJ
authors.lastname: Robert
authors.forename: Tadeusz
authors.initials: T
authors.lastname: Pienkowski
authors.forename: John
authors.initials: J
authors.lastname: Crown
authors.forename: Miguel
authors.initials: M
authors.lastname: Martin
authors.forename: Marek
authors.initials: M
authors.lastname: Pawlicki
authors.forename: Arlene
authors.initials: A
authors.lastname: Chan
authors.forename: John
authors.initials: J
authors.lastname: Mackey
authors.forename: John
authors.initials: J
authors.lastname: Glaspy
authors.forename: Tamás
authors.initials: T
authors.lastname: Pintér
authors.forename: Mei-Ching
authors.initials: MC
authors.lastname: Liu
authors.forename: Tommy
authors.initials: T
authors.lastname: Fornander
authors.forename: Sandeep
authors.initials: S
authors.lastname: Sehdev
authors.forename: Jean-Marc
authors.initials: JM
authors.lastname: Ferrero
authors.forename: Valerie
authors.initials: V
authors.lastname: Bée
authors.forename: Maria J
authors.initials: MJ
authors.lastname: Santana
authors.forename: Dave P
authors.initials: DP
authors.lastname: Miller
authors.forename: Deepa
authors.initials: D
authors.lastname: Lalla
authors.forename: Dennis J
authors.initials: DJ
authors.lastname: Slamon
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D016190:Carboplatin / Q000008:administration & dosage; D003520:Cyclophosphamide / Q000008:administration & dosage; D018572:Disease-Free Survival; D000077143:Docetaxel; D004317:Doxorubicin / Q000008:administration & dosage; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D006801:Humans; D008875:Middle Aged; D009367:Neoplasm Staging; D011788:Quality of Life; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000235:genetics; D011795:Surveys and Questionnaires; D043823:Taxoids / Q000008:administration & dosage*; D000068878:Trastuzumab; D016896:Treatment Outcome
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D016190:Carboplatin; D003520:Cyclophosphamide; D000077143:Docetaxel; D004317:Doxorubicin; D018719:Erb-b2 Receptor Tyrosine Kinases; D043823:Taxoids; D000068878:Trastuzumab; C508053:ERBB2 protein, human
keywords: Adjuvant therapy; Anthracycline-induced cardiotoxicity; BCIRG 006; Breast cancer; Chemotherapy; Docetaxel; Quality of life; Trastuzumab